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International Journal of Drug Research and
Technology
Available online at http://www.ijdrt.com
Research Article
STUDY OF ANTIHYPERTENSIVE DRUG UTILIZATION PATTERN
IN CHRONIC KIDNEY DISEASE PATIENTS
Amish Uprety*
Nargund College of pharmacy Bangalore, Karnataka, India.
ABSTRACT
Introduction: Hypertension is a chronic illness associated with high morbidity & mortality,
with a rising number of patients with hypertension and chronic kidney disease, achieving
blood pressure of less than 140/90 mm of Hg is challenging. Hence, there is a need for
appropriate, safe, effective and economical study to find out the patterns of drug therapy.
Objectives: To evaluate utilization patterns of antihypertensive agents in chronic kidney
disease patients.
Methodology: A prospective observational study was conducted for a period of 6 months in
Jayanagar General Hospital, Bengaluru. We included 70 hypertensive CKD patients. Detailed
patient information data were noted, and data entered in a preformed proforma in Microsoft
Excel sheet for compilation and subjected to statistical analysis.
Results: Total 70 case records of patients having chronic kidney disease were analysed.
Mean age was 52.08 ± 15.14. CKD was more prevalent in males 38 (54.2%) and 32 (46.8%)
females with male to female ratio of 2.3:2. Most of the patients (52.80%) belonged tote age
group of 41-60 years. Among the anti-hypertensive agents, most frequently used was calcium
channel blockers (91.4%), followed by diuretics (54.2%), Beta blockers (31.4%), alpha
blockers, ACE inhibitors and ARB.
Conclusion: Dual and triple therapy were prescribed which was according to ESH
guidelines. This study highlights some therapeutic rationality in this health centre. However,
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targeted education of the prescription-givers and dissemination of treatment guideline could
facilitate rational use of drugs and adherence to treatment guidelines.
Keywords: Hypertension; Chronic kidney disease; Drug utilization; ESH Guidelines;
Treatment.
INTRODUCTION
According to WHO, Hypertension is defined as a systolic blood pressure (SBP) of 140
mmHg or more, or a diastolic blood pressure (DBP) of 90 mmHg or more. Hypertension is a
common disease that is simply defined as persistently elevated arterial blood pressure (BP).
Although elevated BP was perceived to be “essential” for adequate perfusion of essential
organs during the early and middle 1900s, it is now identified as one of the most significant
risk factors for cardiovascular (CV) disease. Increasing awareness and diagnosis of
hypertension, and improving control of BP with appropriate treatment, are considered critical
public health initiatives to reduce CV morbidity and mortality. Hypertension is an important
public health challenge in both economically developing and developed countries. In India,
cardiovascular diseases (CVDs) are estimated to be responsible for 1.5 million deaths
annually. Hypertension is a major risk factor for CVDs, including stroke and myocardial
infarction, and its burden is increasing disproportionately in developing countries as they
undergo demographic transition.
Complications of Hypertension
Stroke
Cerebral/brainstem infarction
Cerebral haemorrhage
Lacunar syndromes
Multi-infarct disease
Hypertensive encephalopathy/ malignant hypertension
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Dissecting aortic aneurysm
Hypertensive nephron-sclerosis
Peripheral vascular disease (Walker R et al., 2012)
Globally CKD is a major threat because of an increasing incidence, long term hospital stay,
high cost of treatment and poor outcome associated with various complications and co-
morbidities. CKD is an array of heterogeneous disorders affecting renal architecture and
function as well. The Kidney Disease Outcomes Quality Initiative (KDOQI) of the National
Kidney Foundation defines CKD as kidney damage and/or a decreased glomerular filtration
rate of less than 60 mL/min/1.73 m2
for three months or more. Hypertension (HTN) has been
reported in most of patients with CKD (Stages III-V). (Kearney PM et al., 2004)
In India, the incidence of CKD is rising, and as per estimates from 006, the age-adjusted
incidence rate of end-stage renal disease (ESRD) is 229 per million populations. Further, the
number of new patients entering renal replacement programs annually is >100,000. The
rising incidence of CKD in India is likely to burden healthcare and the economy in the future
(Walker R et al., 2012).
Study Criteria
Inclusion Criteria:
Patients treated for hypertension and chronic kidney disease with or without other co
morbid conditions like Diabetes mellitus, and other associated cardiovascular
diseases.
Exclusion Criteria:
Pregnant and lactating patients.
Age below 18 and above 90 years.
Terminally ill patients co-infected with HIV or Hepatitis or with any infective
conditions or with any autoimmune diseases or continuing medications for the same.
Patients with renal transplant.
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MATERIAL AND METHODS
A descriptive, prospective and hospital-based study was conducted in Jayanagar General
Hospital, Bangalore over a period of 6 months, after obtaining the clearance and approval
from the Institutional Ethics Committee, 70 in-patients were included in the study. The
patients were diagnosed of having Chronic Kidney Disease by the consultant Nephrologist
according to KDOQI guidelines.
Statistical analysis
Descriptive statistics is done by measuring different proportions. statistical measurement was
done in SPSS trial version 24.0. Graphical representation was done in using Microsoft Excel.
RESULTS
Gender wise distribution
During the study period, a total of 70 hypertensive patients were included. Out of 70 patients,
38 (54.2%) were male and 32 (45.8%) were females (Table 1 and Figure 1).
Table 1: Gender wise distribution of patients
S. No Gender Numbers Percentage (%)
1 Male 38 54.2
2 Female 32 45.8
Figure 1: Gender wise distribution of patients.
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Age wise distribution
Out of 50 patients, 37 (52.8%) belonged to age group of 41-60 years, followed by 17 (24.2%)
belonged to 61-80 years and 12 (17.1%) belonged to 21-40 years. Mean age in study subject
was 52.08 ± 15.14 years (Table 2).
Table 2: Age wise distribution of hypertension
S. No Age group Total No Males Females Total percentage (%)
1 18-20 2 1 1 2.8
2 21-40 12 6 6 17.1
3 41-60 37 23 14 52.8
4 61-80 17 7 10 24.2
5 >80 2 1 1 2.8
Distribution of patients based on social habits
Out of 70 patients, we found that 13 (18.5%) patients were smokers alone in which 8 (61.5%)
were males and 5 (38.4%) were females and 14 (20%) patients were alcoholic in which 8
(57.1%) were males and 6 (42.8%) were in females. Patients having habit of both alcoholic
and smoking were found to be 23 (32.8%) in which 19 (82.6%) were males and 4 917.3%)
were females. 20 patients have not had any habits mentioned (Table 3).
Table 3: Social habits of the patients
S. No. Social Habits Total Male Female
1 Smokers 13 8 5
2 Alcoholics 14 8 6
3 Both 23 19 4
4 None 20 3 17
Comorbid conditions
Majority of the patients were suffering from concurrent diabetes mellitus (50%). Other
commonly associated conditions were Anaemia (15.7%), Cardiovascular Disease (0.42%),
Urinary Tract Infection (0.57%), Chronic Liver Disease (0.14%), Pulmonary Tuberculosis
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(0.14%), Hypothyroidism (0.28%), Retinopathy (0.14%) and Seizures (0.14%) (Table 4 and
Figure 2).
Table 4: Co-morbid conditions.
S. No Co-morbid conditions Total Male Female
1 Diabetes Mellitus 35 16 19
2 Anemia 11 6 5
3 Cardiovascular Disease 3 1 2
4 Urinary Tract Infection 3 1 2
5 Chronic Liver Disease 1 1 0
6 Pulmonary Tuberculosis 1 1 0
7 Hypothyroidism 2 0 2
8 Retinopathy 1 1 0
9 Seizures 1 1 0
Figure 2: Co-morbid conditions.
Antihypertensive drugs use pattern
In our study, out of 70 patients we concluded that 39 patients had received two anti-
hypertensive drugs (55.7%), followed by both one and three anti-hypertensive drugs (25.7%)
and four antihypertensive drugs. Among the antihypertensive drugs, amlodipine (CCB) was
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the most commonly prescribed drug (80%) followed by furosemide (loop diuretic) (48.5%),
metoprolol (beta blocker) (31.4%), cilnidipine (CCB) (11.4%), torsemide (diuretic) (5.7%)
telmisrtan (ARB) (5.7%), losartan (ARB) (2.85%), prazosin (alpha blocker) (10%), clonidine
(centrally acting alpha-agonist) (10%), metoprolol (beta blocker) (4%) and enalapril (ACEI)
(1.42%), chlorothalidone (thiazide diuretic) (1.42%),captopril (ACEI) (1.42%) (Table 5 and
Figure 3).
Table 5: Number of prescriptions with anti-hypertensive drugs.
S. No Anti-Hypertensive Drugs either given alone or in
Combinations
Percentage of
Prescriptions
1 Patients treated with Calcium channel blocking agents 91.4
2 Patients treated with Beta - Adreno receptor Blocking agents 31.4
3 Patients treated with Diuretics 54.2
4 Patients treated with ACE inhibitors 2.85
5 Patients treated with Alpha – adreno receptor Blocking agents 10
6 Patients treated with Angiotensin Receptor Antagonist 8.5
7 Patients treated with Centrally acting anti-hypertensive agent
(Clonidine) 10
Figure 3: Anti-hypertensive agents use pattern.
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Combination therapy (Table 6)
Table 6: Number of combination therapy.
Therapy No. of Prescription Percentage (%)
Mono therapy 18 25.7
Dual Therapy 29 41.4
Triple Therapy 18 25.7
Combination of four 5 7.14
Percentage adherence to ESH 2018 GUIDILINES: HT+CKD
Out of 70 patients 47 were prescribed in accordance to the ESH guidelines European society
of hypertension. Percentage adherence to ESH guideline in relation to treatment of
hypertensive patients with compelling indication (s) was found to be 67.1% (Table 7).
Table 7: Percentage adherence to European society of hypertension.
Variables No. of prescriptions Percentage (%)
Adherence 47 67.1
Nonadherence 23 32.9
Categorization of hypertensive patients based on blood pressure reading
In our study that included 70 hypertensive CKD patients, 5 were having severe hypertension
requiring intensive anti-hypertensive therapy with more than one antihypertensive agent, 13
were having moderate hypertension requiring pharmacological intervention and remaining 32
were in controlled blood pressure. The categorization is done based on ESH Guidelines 2018
(Table 8 and Figure 4).
Table 8: Categorization of hypertensive patients based on blood pressure reading.
S. No. Blood Pressure Reading No. of Patients
1 Hypertension (Grade 1) 16
2 Hypertension (Grade 2) 7
3 Hypertension (Grade 3) 13
4 Hypertension (Normal) 13
5 Hypertension (High Normal) 21
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Figure 4: Categorization of hypertensive patients based on blood pressure reading (ESH
Guidelines 2018).
Categorization chronic kidney disease patients according to eGFR with MDRD Method
Out of the 70 patients, 42 patients were in stage 5 (60%) among them 26 (61.9%) were male
and 16 (38.09%) were female. 13 were in stage 4 (18.5%) among them 6 (46.1%) were male
and 7 (53.85) were female. 13 patients were in stage 3 (18.5%) among that 4 (30.7%) were
male and 9 (69.2%) were male. 1 patient in stage 1 and 1 patient in stage 2 which of them
were male (Table 9 and Figure 5).
Table 9: Categorization chronic kidney disease patients according to eGFR with MDRD
method.
S. No. Stages Total patients Male Female
1 Stage 1 1 1 0
2 Stage 2 1 1 0
3 Stage 3 13 4 9
4 Stage 4 13 6 7
5 Stage 5 42 26 16
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Figure 5: Categorization chronic kidney disease patients according to eGFR with MDRD
method.
DISCUSSION
Drug utilization study is described as “The marketing, distribution, prescription and
utilization of drugs in the society, with special attention to the resulting medical, social and
economic consequences” and has the main objective of facilitating the rational use of drugs
which is very important in decision making for healthcare set ups. A prescription survey is
one of the most effective methods to evaluate the prescribing attitude of doctors. It is also
important to consider the guidelines of international regulatory associations on the
management of hypertension that will improve prescribing practice of the physicians and
ultimately, the clinical standards. This practice will eventually, help to promote rational use
of drugs (Abhisek PA et al., 2017).
The study on antihypertensive drug utilization pattern in presence of chronic kidney disease
included 70 patients. According to gender wise distribution it was found that males were
slightly more predisposed to the HTN with CKD than females. A similar study concluded
that male population was (58.4%) slightly at the higher end for the condition than the
females, which was like our study (Sarafidis PA et al., 2012; Verberne WR et al., 2019).
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Another study in Odisha reveals the mean age of the hypertensive CKD patients was 49.26
±11.46 years somewhat close to our study results that is 52.08 ± 15.14 years (Abhisek PA et
al., 2017).
In our prescription-based survey, the prominent findings were, out of 70 prescriptions, most
of the subjects were of the age group between 41-60 years of age. Two patients were found
between 18-20 and two above 80 years of age, this distribution shows that the age group of
41-60 were more prone to have CKD along with hypertension. According to a study
conducted in Cuttack, majority of the patients were in the age group of 41-60 years compared
to other age groups reflecting the similar pattern with our study years (Abhisek PA et al.,
2017).
In our survey, combination therapy was most widely prescribed regimen by the physicians.
Earlier studies have revealed that an ideal combination must have antihypertensive drugs
possessing complementary modes of action that provide a synergistic effect with minimal
adverse effects. Most hypertensive diabetic patients with normal renal function require a
combination of two to three antihypertensive agents to lower blood pressure to <130/80
mmHg; patients with concomitant chronic kidney disease may require three or more agents.
Combination therapy is required for optimal blood pressure control and prevention of
cardiovascular, renal and neurological complications.
Out of 70 patients, we found that 13 (18.5%) patients were smokers alone in which 8 (61.5%)
were males and 5 (38.4%) were females and 14 (20%) patients were alcoholic in which 8
(57.1%) were males and 6 (42.8%) were in females. Patients having habit of both alcoholic
and smoking were found to be 23 (32.8%) in which 19 (82.6%) were males and 4917.3%)
were females. 20 patients have not had any habits mentioned.
In this survey, most commonly prescribed monotherapy was calcium channel blocker (80%)
in our study corroborate with the study (Bailie GR et al., 2005). In our study the second most
used mono therapy was by loop diuretics (48.5%) however in another study, the most
prescribed drug class was ACE inhibitors /ARB which is not similar with our results. In
elderly patients, the preferred antihypertensive by the physicians were calcium channel
blockers (Magvanjav O et al., 2019).
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Our study elicited that most of the patient who were hospitalized were in Stage V (60%)
followed by stage 4 (18%) and stage 3 (18%).
Co-morbidities associated with hypertension and CKD were seen in all 52 patients, Diabetes
mellitus in 67.3%, anaemia in 21% and other conditions included urinary tract infection and
those related to CVS. Most of the studies have shown diabetes mellitus as the favourite co-
morbidity in the similar patients.
These findings indicate that medication use was consistent with the international
recommendations from JNC 8 and European Society of Hypertension among hypertensive
CKD patients (James PA et al., 2014).
CONCLUSION
Amlodipine and furosemide were the most frequently prescribed antihypertensive drugs.
Prescription of antihypertensive drugs for some patients with compelling indications
(specifically CKD), were very much congruent with ESH guideline. This study highlights
some therapeutic rationality in this health centre. However, targeted education of the
prescription-givers and dissemination of treatment guideline could facilitate more rational use
of drugs and better therapeutic outcomes.
Control of hypertension and maintenance of ideal blood pressure is the root point that would
benefit the CKD patients most maintaining their renal health and related complications.
Pharmacists must become more vigilant about current guidelines for the treatment as well as
the ADR detection of some antihypertensive which can impact renal functions on patients
with concomitant hypertension and Chronic Kidney Disease.
Strategies such as patient education and medication assessment can help to optimize care for
these patients and slow the progression to chronic kidney disease. Many patients with CKD
and hypertension are still out of reach of specialized care. Specific risk factors determined
may aid in identifying patients at high-risk for inadequate treatment. Patient and education
provider, public health approaches, and health system changes are needed to address these
issues. As the population grows older renal function also tend to decrease proportionally,
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hence kidney injuries becomes more prominent at the same time condition as hypertension
tend to double the risk factor for such age group.
LIMITATIONS
In spite of several limitations like inadequate sample size, study duration, point prevalence
nature of the collected data and being unicentric, this study provided a profile of drug
utilisation pattern in hypertensive CKD patients compared by class and also individualistic
comparison of drugs in the same class. This study will serve as a basis for future comparison.
Certain areas like potential drug-drug interaction, AEs and adherence are needed to be
explored further.
Fair portion of the drugs were prescribed from the prescribers and all the available
medication in hospital were written in generic name. So, it is the need of the hour to avail all
the required medication in the institution to prescribe rationally. Continuous prescription
audit from the clinical pharmacists in government sector will improve the utilization pattern
and therapeutic outcomes in economically challenged hypertensive CKD patients.
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Correspondence Author:
Amish Uprety*
Nargund College of pharmacy Bangalore, Karnataka, India.
E-mail: [email protected]
Tel: +917022670315
Cite This Article: Uprety A (2019) “Study of antihypertensive drug utilization pattern in
chronic kidney disease patients.” International Journal of Drug Research and Technology
Vol. 9 (3) 252-270.